During this fiscal year, two interim analyses of the phenobarbital clinical study data were performed for evaluation by the Performance and Safety Monitoring Committee. The system program for monitoring patient statis and data tracking have been modified to accommodate the need for more frequent and closer monitoring of the trial's progress. Accumulating data are continually being analyzed for consistency and for deviations from protocol using the OBFS H-P clinical trials computer management system. All edited data are transferred from the H-P to the DCRT, NIH computer where data analysis files are created and maintained.